MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA BLOOD COLLECTION; COBE SPECTRA WHITE BLOOD CELL SET, CLOSED

Catalog Number 70620

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/17/2015

Event Type  Injury  

Manufacturer Narrative

Investigation: fluids hanging were acda and 0.9% normal saline.Per the customer, the patient physician was apprised of the extra volume.Cd 34 goal from collection was achieved.A service call was placed for the machine.The reported condition could not be duplicated during service.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that they had a higher than expected product volume collected on a mononuclear cell (mnc) collection procedure.The cobe spectra displayed that the collected volume was 218ml when the actual collected volume was 680ml.No medical intervention was required for this event and no additional follow-up visit was necessary.Per the customer, the patient is in stable condition post collection and had no issues.The disposable kit is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The values provided, along with the extra-corporeal volume (ecv) of the disposable set, were used to calculate the intended fluid balance (fb) versus the actual fb of the patient at the conclusion of the procedure.The intended fb was calculated to be total blood volume (tbv) 5188ml.Considering the original tbv of 4019ml, the total fb is 129% of the original tbv.The actual fb was also calculated using the 680ml of collected product.This equals an actual tbv of 4726ml and 117% of the original tbv.The difference between the two fb values is greater than the tolerances of the pumps.Root cause: a definitive cause for the overall product volume could not be determined.The service call did not reveal any abnormalities with the machine and the disposable set was unavailable for further analysis.Possible causes include, but are not limited to, a partial occlusion in the tubing set or tubing not fully set in the pump raceway.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA WHITE BLOOD CELL SET, CLOSED
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w. collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5289418
• MDR Text Key: 33279482
• Report Number: 1722028-2015-00647
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK080035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2017
• Device Catalogue Number: 70620
• Device Lot Number: 08Y15244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2015
• Initial Date FDA Received: 12/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 74